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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001280-77 | EudraCT Number |
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The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.
The study consists of different parts. Part A of the study will consist of once daily (OD) cohorts (OD Cohort 1 to 3), as well as twice daily (BID) cohorts (BID Cohorts A1 and A2). Part B will consist of 3 cohorts (Cohorts B1, B2, and B3) whereby participants will be administered Lu AF28996 BID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF28996 | Experimental | Participants in Part A will receive ascending oral doses of Lu AF28996 OD for 14 days in all OD cohorts, followed by down-titration as per Investigator's judgement. For the BID Cohort A1, participants will receive Lu AF28996 BID for 24 days, followed by down-titration as per Investigator's judgement. For the BID Cohort A2, participants will receive Lu AF28996 BID for 39 days, followed by down-titration as per Investigator's judgement. Participants in Part B (Cohorts B1, B2, and B3) will receive Lu AF28996 BID for 41 days, followed by down-titration as per Investigator's judgement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF28996 | Drug | capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination) | From Baseline to 5.5 Months |
| Cmax of Lu AF28996 | Maximum observed plasma concentration of Lu AF28996 | 0 (predose) to 24 hours postdose on Day 1 to Day 47 |
| Tmax of Lu AF28996 | Nominal Time Corresponding to the Occurrence of Cmax | 0 (predose) to 24 hours postdose on Day 1 to Day 47 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel Los Alamitos | Los Alamitos | California | 90720 | United States | ||
| Georgetown University |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Velocity | Hallandale | Florida | 33009 | United States |
| Parkinson's Disease Treatment Center of SW FL | Port Charlotte | Florida | 33980 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Neurology Consultants of Nebraska | Omaha | Nebraska | 68154 | United States |
| Inland Nortwest Research | Spokane | Washington | 99202 | United States |
| Caen Normandy University | Caen | Basse-Normandie | 14033 | France |
| Curiositas-ad-sanum | Hamburg | 83527 | Germany |
| QPS Netherlands BV | Leeuwarden | 8934 AD | Netherlands |
| Hospital Vall d“Hebron | Barcelona | 08035 | Spain |
| Hosp. General Catalunya | Mira-Sol | 08195 | Spain |
| Virgen Del Roccio | Seville | 41013 | Spain |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |